A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the V520 Vaccine in Adults at High Risk of HIV-1 Infection.

Trial Profile

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the V520 Vaccine in Adults at High Risk of HIV-1 Infection.

Completed
Phase of Trial: Phase II

Latest Information Update: 12 Nov 2014

At a glance

  • Drugs V 520 (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms STEP
  • Sponsors Merck & Co; Merck Sharp & Dohme
  • Most Recent Events

    • 18 May 2012 Primary endpoint 'Occurrence-of-infection' has not been met.
    • 22 Dec 2009 Planned number of patients changed from 1500 to 3000 as reported by ClinicalTrials.gov (NCT00095576).
    • 22 Dec 2009 Planned number of patients changed from 1500 to 3000 as reported by ClinicalTrials.gov (NCT00095576).
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